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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02370147
Other study ID # ChinaPLAGHW
Secondary ID
Status Not yet recruiting
Phase N/A
First received February 10, 2015
Last updated February 23, 2015
Start date March 2015
Est. completion date June 2017

Study information

Verified date February 2015
Source Chinese PLA General Hospital
Contact n/a
Is FDA regulated No
Health authority China: Ethics Committee
Study type Interventional

Clinical Trial Summary

A two-arm randomized controlled trial for smokers who are not intent to quit smoking will be proposed in outpatient department clinics of People's Liberation Army General Hospital in Beijing, China. Smoking reduction intervention arm (SRI) consisting of a very brief face-to-face individual smoking reduction intervention lasted about one minute, and five follow-up interventions lasted for about minute each. Control arm (EDA) consisting of a very brief face-to-face individual exercise and dietetic advices lasted for the same intervention time as SRI, and also five follow-up interventions lasted for one minute each with different intervention contents.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 500
Est. completion date June 2017
Est. primary completion date December 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

1. Aged =18 years old;

2. Smoked more than 10 cigarettes per day in the past month.

3. Have no intent to smoking cessation now.

4. Agreed to participate in the follow-up, offer telephone number and signed an informed consent form.

Exclusion Criteria:

1. Smoked less than 10 cigarettes per day in the past month.

2. Had some diseases that let the physician think that it would be unethical not to advise him to quit smoking as soon as possible.

3. Cognitively impaired (such as those with deafness or who could not understand and complete the questionnaire reliably).

4. Pregnant females.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research


Related Conditions & MeSH terms


Intervention

Behavioral:
Smoking reduction intervention
Smokers was informed that many harmful effects were proved to be related with smoking, such as cancer, coronary heart disease, respiratory disease and many other health problems, and one out of two smokers will be killed by smoking. Smokers will be advised to reduce smoking consumption for at least half of their total consumption in the next month. Finally, all smokers were warned to keep in mind that the current attempt to reduce smoking is an intermediate step before the complete cessation.
Exercise and diet advice control
Smokers will be asked to do regular activities for three or four times per week, and to have a healthy and balanced diet, having more fruit and vegetables which are rich in vitamins, high in nutrition yet low in calories. In the whole process, advises will not refer to smoking cessation or smoking reduction.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Chinese PLA General Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary self-reported 7-day point prevalence quit rate at 12 months follow-up No
Primary prolonged abstinence quit rate at 12 months follow-up No
Secondary smoking reduction rates number of cigarettes smoked per day reduced at least 50% baseline and at 12 months follow-up No
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